Ensuring Quality and Compliance: The latest Good Distribution Practices for Pharmaceuticals and Medical Devices in Taiwan

Ensuring Pharmaceutical Quality: Taiwan's GDP Compliance

The Taiwan Food and Drug Administration (TFDA) places a strong emphasis on ensuring the quality of distribution practices for pharmaceutical products. To achieve this goal, TFDA has adopted global standards such as the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to Good Distribution Practice for Medicinal Products (PE011-1). TFDA has also developed its own version of the Good Distribution Practice (GDP) guidance based on these standards.

Compliance with GDP guidelines is crucial as it ensures the integrity, efficacy, and safety of pharmaceutical products throughout the supply chain. GDP serves as an extension of Good Manufacturing Practice (GMP) and plays a vital role in quality assurance. Non-compliance can lead to disruptions in business operations and result in penalties.

Latest GDP Implementation Announced by TFDA

TFDA has implemented specific requirements for pharmaceutical companies involved in the distribution of pharmaceuticals. It has been issued as a series of announcements outlining the necessary steps and timelines for compliance. These announcements include deadlines for obtaining pharmaceutical distribution permits based on specific product categories.

The following is TFDA announced draft of the latest GDP implementation items and timelines:

While GDP compliance is mandatory, quality issues may still arise during storage and distribution. For example, the presence of product discrepancies, the presence of illegal products, or changes in product appearance. To address non-compliance issues, companies are required to establish their own Standard Operating Procedures (SOPs) or agreements with third parties, outlining corrective and preventive actions.

Mandates GDP-compliant system for high-risk medical devices.

In addition to pharmaceutical products, certain high-risk medical devices in Taiwan are also required to comply with the Medical Device Act and establish a GDP-compliant distribution system starting from May 1, 2023. This requirement applies to manufacturers, agents, distributors, and license holders handling class III high-risk medical devices, including those classified as class II under N.3030 (single/multiple components, metallic bone fixation appliances, and accessories).

To maintain compliance with GDP regulations, the Taiwan Food and Drug Administration (TFDA) carries out inspections and grants certificates that are valid for a period of three years. It is recommended that medical device companies take a proactive approach by implementing a GDP system for products that are not currently included within the scope. This is important because TFDA may periodically update the list of items that fall under GDP compliance requirements. By establishing a robust GDP system, companies can ensure they are prepared for any future expansions of the compliance scope and maintain regulatory compliance effectively.

GDP Non-compliance: Audits and Serious Consequences

Non-compliance with GDP regulations for pharmaceuticals and medical devices carries serious consequences. Non-compliance will cause business suspension and administrative penalties. To mitigate the risk of non-compliance, conducting self-inspections or inspections of distributors, transportation companies, manufacturers, and packaging sites can be effective measures. These inspections require documentation such as product quality manuals, manufacturing procedures, registration records, and agreements with contracted distributors. These documents demonstrate adherence to distribution control requirements, including documentation management, management responsibilities, resource management, client feedback, procurement processes, traceability, product protection, equipment control, analysis, and improvements. Agreements with third parties should also be reviewed and modified in line with GDP guidelines.

To support clients in achieving GDP compliance, ERM provides comprehensive and efficient services aimed at establishing robust GDP systems and documentation. Our expertise enables us to assist clients in meeting the requirements of Good Distribution Practices and developing strategic plans to ensure successful GDP compliance. We welcome you to contact ERM for further information and discover how we can help your organization navigate the complexities of GDP regulations and achieve compliance effectively.